Small Companies Facing FDA Issues

A recent report in the June issue of Journal of Medical Devices (Article) highlights the issues facing small companies that deal with the FDA to get medical devices approved.  The study found that predictability of the regulatory process in the United States is a key priority given that two-thirds of the medical device companies surveyed listed this issue as "critically important."

Four other key areas for improvement were also highlighted in the report:

  • Regulatory requirements. More than half of survey respondents cited regulatory requirements as one of the top three factors in investment decisions about proceeding with a new device. Almost a quarter of respondents cited it as the top factor.
  • Guidance documents. More than two-thirds of respondents felt device-specific guidance documents were critical to preparing a successful submission; 59% stated that device-specific guidance did not exist for their technology.
  • Interaction with US FDA. In almost nine out of 10 cases, FDA reviewers asked for additional information on a submission that went beyond what was required in guidance documents, according to survey participants.
  • International experience. Compared with the EU process, the US FDA review process was found to be almost twice as long for devices not requiring clinical data and almost three times as long for devices that do.

In another article from last year in the Star Tribune (Article) reported on the Town Hall meetings the FDA held to solicit feedback from industry.  The feedback echoes that of the Journal of Medical Devices Survey.

FDA Officials held a town hall meeting at University Enterprise Laboratories in St. Paul Minnesota on Tuesday (8/2/2011) to solicit feedback and ideas from industry.

Summary comments from Industry:

The agency's approval process needs to become more predictable and transparent.

Randy Nelson, president of St. Paul-based Evergreen Medical Technologies, said many small device companies seeking FDA approval for their products are hesitant to talk to the agency "because you never get the same answer."

The Food and Drug Administration is looking for more input after receiving a recommendation last week that it scrap a controversial pathway for medical device approvals and designed a new process.

FDA officials told device industry executives at a town hall meeting in St. Paul on Tuesday that they remain open to ideas to improve the 510(k) method of device reviews, which generally doesn't require clinical trials. The agency is gathering public comment, a process that should be complete by October.

"Let's have that discussion," said Dr. Jeffrey Shuren, head of the FDA's device division. "If there are any recommendations that make sense, we'll consider them."

Friday's recommendations from the prestigious Institute of Medicine (IOM) disappointed many in Minnesota's formidable medical technology community.

But Shuren, who appeared with his four top lieutenants, said Tuesday that the kind of drastic overhaul the IOM recommends is probably not necessary. "I don't think we should eliminate [the 510(k)] process in its entirety. It does have a role, it needs some fine-tuning."

In 2009, FDA asked the IOM, part of the National Academy of Sciences, to review the approval pathway after several safety recalls of medical devices in recent years.

In a town hall meeting at University Enterprise Laboratories in St. Paul, Shuren and his staff answered questions from the Twin Cities' med-tech elite for about an hour. The general theme: The agency's approval process needs to become more predictable and transparent, a common gripe levied by med-tech companies against the agency.

Randy Nelson, president of St. Paul-based Evergreen Medical Technologies, said many small device companies seeking FDA approval for their products are hesitant to talk to the agency "because you never get the same answer."

William Maisel, deputy center director for science and the device division's chief scientist, said it's "very important that you talk to us. We believe you are better off talking to us."

A quality program to monitor the advice FDA gives to applicants has been instituted to ensure a consistent, and therefore predictable, experience for companies when dealing with the FDA, he said.

About 60 people attended the town hall meeting Tuesday, which was planned long before the IOM controversy. It was the second town hall meeting the FDA has hosted in Minnesota, home to Medtronic Inc., the world's largest med-tech company, and hundreds of smaller brethren.

One attendee asked what role government should play in retaining highly coveted med-tech companies in the United States, especially after Boston Scientific's announcement last week that it was cutting some domestic jobs but adding 1,000 in China.

While repeating the mantra that FDA needs to be more "predictable, transparent and timely" in its approval process, Shuren said corporate decisions are "due to a lot of factors. Sometimes it's FDA, but not always. Sometimes companies just need people in-country."

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